FDA approves Stivarga for GI stromal tumors
FDA approval was based on study data from patients with inoperable or metastatic GIST who progressed in spite of treatment with imatinib and sunitinib.
(HealthDay News) -- The U.S. Food and Drug Administration has approved the expanded use of the multi-kinase inhibitor Stivarga (regorafenib) to treat patients with advanced gastrointestinal stromal tumors (GIST) that cannot be surgically removed and do not respond to other treatments. The drug was granted orphan product designation because it is intended to treat a rare disease.
The FDA approval was based on data from a clinical study of 199 patients with inoperable or metastatic GIST who progressed in spite of treatment with FDA-approved Gleevec (imatinib) and Sutent (sunitinib). The patients were randomized to receive Stivarga or placebo, and also received optimal supportive care. Patients allocated to receive Stivarga had a 3.9 month delay in tumor growth compared with placebo.
The most common side effects seen with Stivarga included weakness and fatigue, hand-foot syndrome, diarrhea, loss of appetite, nausea, stomach pain, weight loss, hypertension, mouth sores, rash, fever, changes in voice volume or quality, and infection. In addition, serious side effects, noted in less than 1 percent of patients, included liver damage; severe blistering, bleeding, and peeling of skin; very high blood pressure; heart attack; and intestinal perforation. Stivarga was approved in September 2012 to treat colorectal cancer.
Stivarga is marketed by Bayer HealthCare Pharmaceuticals, based in Wayne, N.J.